Risk Evaluation and Mitigation Strategies

This webinar will provide basic understanding of requirements for REMS and offer steps to consider for implementation, Also this webinar addresses development and implementation of a REMS to inform and train patients and caregivers of potential AE and to allow closer monitoring for AE.

Gwendolyn Wise-Blackman
Wednesday, May 8, 2019
10:00 AM PDT | 01:00 PM EDT
60 Minutes

More Trainings by this Expert   Product Id : 502537

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Pharmaceutical and biologic products often have adverse events (AE) that may not be identified until after approval and release.

AE can be observed either in general patient populations of diverse gender, and age or in specific patient populations.Some patient populations have complications of metabolic disease or other disease states that elevate the possibility of an AE.

Additionally, certain patient populations may have difficulty identifying initial effects of an AE or be unable to effectively communicate an issue.These problems are possible whether the patient is at home or in a hospital or other care facility.Effective monitoring with a REMS should help decrease problems associated with patient population that are unable to identify and report issues. Effective training of both the patient and caregivers becomes essential to proper implementation of a REMS.

Identifying biologics that need a REMS and preparing associated documentation is necessary to properly train staff prescribing and dispensing medication as well as staff performing follow-up medical care.

AE may be related to class and structure of the biologic drug. These events may also occur due interactions with other pharmaceutical compounds the patient may be taking for the same disease or for another disease.Risk management must carefully assess the potential for patients to consume other medication that may elevate the likelihood of an AE.

Strategies must be in place if a pharmaceutical or biologic product is deemed to likely have or is observed to exhibit

Pharmaceutical products that target pathways for which other biologics with similar profiles but different structures have documented AE likely will have a conclusion after risk management assessment that a REMS is necessary.

New chemical entities also need a risk assessment based on chemical structure or pathways involved in therapeutic effects. These may be new pathways with no redundancy or known pathways with serious AE associated with either short-term or long-term therapy.

Known AE for similar structures, or lack thereof, can be the initial baseline when determining the level of risk. However, lack of an AE to a biologic targeting a similar pathway does not exempt initiating the process of considering if a REMS is necessary.

To assure public safety, the FDA requires risk evaluation and implementation of a plan designed to mitigate the risk to patient health.

These plans are developed as part of a risk evaluation and mitigation strategy (REMS). REMS are designed to inform medical providers and patients of possible AE and guide the required steps when an event occurs.

Implementation of a REMS will also help mitigate possible AE by providing steps useful for monitoring patient responses to allow for decreasing dosages or other strategies when early signs of an AE are presented to medical personnel.

In addition to monitoring of patients with laboratory testing for critical organ functions, REMS also provides details for training of both the patient and the medical provider on early identification of AE.

Detailed evaluation of the risks, careful development of an action plan, and proper training of all involved with patient care, including family members and the patient, will lead to an effective REMS designed to meet patient safety expectations.

Why should you Attend: Healthcare Adverse events (AE) may not be identified completely prior to release of pharmaceutical or biologic drugs.

These untoward events create a risk for the patient population as well as for the drug owner.Serious AE can lead to FDA recalls. As dosing in the patient population increases post-marketing evaluation is essential to maintaining a safety profile.

Minimization of AE while maintaining therapeutic effect is key. Having a Risk Evaluation and Mitigation Strategy (REMS) is an essential component of product release that

This webinar addresses development and implementation of a REMS to inform and train patients and caregivers of potential AE and to allow closer monitoring for AE.

Assessing the risk associated with new pharmaceutical entities or biologic compounds requires a detailed understanding of pathways involved in the therapeutic effect as well as the potential for interference with physiological processes for which the compound may have an impact.

Determining suitable monitoring strategies through testing and assessment of specific patient responses offers a mechanism for collection of data that can lead to advance warning of a potential AE.

Those working in patient care settings, patient monitoring, dispensing of pharmaceuticals or biologics, at-home care, and patient support service should consider attending this webinar to either become familiar with REMS, refresh knowledge, or receive updated information on implementation of REMS.

Attendees will receive knowledge on important and essential requirements related to REMS for potential pharmaceutical adverse effects.This webinar will provide basic understanding of requirements for REMS and offer steps to consider for implementation.

Areas Covered in the Session:

  • Risk Management and Risk Minimization Action Plans 2005
  • Consequences of FDAAA 2007
  • Impact of failed risk management
  • Assessing the potential need for a REMS
  • Responding to a requirement for a REMS
  • Voluntary submission of a REMS
  • Setting timelines
  • Patient registry
  • Patient training
  • Compliance issues

Who Will Benefit:
  • Pharmaceutical Regulatory Affairs
  • Biopharmaceutical Regulatory Affairs
  • Pharmacists
  • Hospital Personnel
  • Physicians
  • Nurses
  • Consultants
  • Home Health Care Agents

Speaker Profile
Gwen Wise-Blackman, Ph.D. has over 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), and Salix Pharmaceuticals where she successfully managed multiple projects and held positions of increasing accountability for scientific and quality expertise. Currently she is the owner of Gwen Wise-Blackman Consulting, LLC, a biopharmaceutical consulting firm.

Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, Ligand Binding Methods, Technology Transfer, GxP Regulations, Training, Audting, and Quality Assurance.

Dr. Wise-Blackman has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from the University of Virginia. She is a member of ASQ and AAPS.

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